Single Port Robotic Lung Anatomical Resection

NCT05535712 | Unknown DMC

• 1 other identifier: 202101423A0
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform

Conditions

Robotic Surgical Procedure

Keywords

Early Stage Lung Cancer; Da Vinci SP; Robotic Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of conversion rate

  The primary performance endpoint will be assessed as the ability to successfully complete the planned anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.

  During Surgery

Secondary Outcomes (6)

• Incidence of Treatment Related Adverse Events

  One Year

• Peri-operative parameters

  From Surgery to ward,2- day

• Peri-operative parameters: blood loss related

  During surgery

• Hospitalization parameters

  During Hospitalization, an average of 4 days

• Operative related complications during hospitalization

  During Hospitalization, an average of 4 days

Other Outcomes (6)

• 30-day follow-up

  Post-operative data through 30-day follow-up

• Questionnaire assessment (1)

  Through study completion, an average of 1 year

• Questionnaire assessment (2)

  Through study completion, an average of 1 year

Study Arms (1)

Da Vinci SP intervnetion group

EXPERIMENTAL

for patients who received Da Vinci SP robotic surgery

Device: Lung Anatomic Resection (Da Vinci SP)

Interventions

Lung Anatomic Resection (Da Vinci SP) DEVICE

To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection

Da Vinci SP intervnetion group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>20 and \<75 years-old
• Willing and able to provide informed consent
• ASA≤ 3
• The subject is undergoing the following procedures
• diagnosis with of clinical stage I lung cancer
• The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus
• Preoperative platelet count 150-400 (1000/ uL)

You may not qualify if:

• Congestive heart failure (NHYA \> II)
• Subjects with a known bleeding or clotting disorder
• Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation
• Subjects under immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery
• Subjects with pulmonary hypertension
• In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty)
• Previous ipsilateral thoracic surgery or sternotomy
• Uncontrolled illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Previous neoadjuvant medical and/or radiation therapy
• Subject has a contraindication for general anesthesia or surgery
• Life expectancy \< 6 months
• Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
• Subjects belong to vulnerable population (e.g., pregnancy or breastfeeding)
• International normalized ratio, INR \>1.4
• Activated Partial Thromboplastin Time , APTT \>35 -

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memeorial Hospital, Linkou Medical Center

Taoyuan District, Taiwan

Location

Related Publications (1)

• Cheng C, Tagkalos E, Ng CB, Hsu YC, Huang YY, Wu CF, Chao YK. Subcostal uniportal robotic anatomic lung resection: A pilot trial. JTCVS Tech. 2024 Apr 28;25:160-169. doi: 10.1016/j.xjtc.2024.01.024. eCollection 2024 Jun.

  PMID: 38899114 DERIVED

Study Officials

• Yin Kai Chao, MD,PHD

  CHENG GUNG MEMORIAL HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: clinical lung cancer who receive Da Vinci sp robotic surgery

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: September 10, 2022
• Study Start: October 7, 2022
• Primary Completion: May 5, 2024
• Study Completion: May 5, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)